Medical device having removable deployment device and affixation element

ABSTRACT

A medical device including a first layer having an opening formed therein. A second layer is positioned with respect to the first layer to form a pocket therebetween. A support member is at least partially located in the pocket and reconfigurable for removal of the support member from the pocket via the opening. An affixation element located in the pocket between the support member and the second layer, and secured to the second layer. A method of implanting a medical device is also included.

BACKGROUND

Prostheses are known in the medical device industry for the repair ofhernias and other tissue structure defects. Various designs have beeninvented and commercialized to handle an increasing array of situationsor to an increasing degree of efficacy. The industry would well receiveadditional advancements and alternates in this field.

SUMMARY

A medical device including a first layer having an opening formedtherein. A second layer is positioned with respect to the first layer toform a pocket therebetween. A support member is at least partiallylocated in the pocket and reconfigurable for removal of the supportmember from the pocket via the opening. An affixation element located inthe pocket between the support member and the second layer, and securedto the second layer.

In one embodiment, the affixation element is secured to the second layerat a securement region, and the affixation element is secured to thesecond layer at a location separate from the securement region. In oneembodiment, the affixation element is at least partially blocked fromaccess through the opening when the support member is located in thepocket. In one embodiment, the affixation element is able to at leastpartially extend out from the pocket through the opening when thesupport member is removed from the pocket. In one embodiment, theaffixation element is at least partially formed by a mesh material. Inone embodiment, the medical device can be held against an anatomicalstructure by the support member when the support member is at leastpartially located within the pocket, and by the affixation element whenthe support member is fully or at least partially removed from thepocket.

In one embodiment, the pocket is delimited by an underside surface ofthe first layer and an upper surface of the second layer. T In oneembodiment, a tensile force is able to be applied to the medical deviceat (i) the underside surface of the first layer by the support memberand (ii) at the upper surface of the second layer by the affixationelement.

In one embodiment, the support member has at least one dimension that islarger than a corresponding dimension of the opening to frustrate orimpede removal of the support member from the pocket. In one embodiment,the support member is reconfigurable in response to a tensile forceapplied to the support member in order to remove the support member fromthe pocket via the opening. In one embodiment, the affixation elementincludes one or more tabs extending from a hub and the hub is affixed tothe second layer. In one embodiment, the affixation element has acircular shape or a polygonal shape.

In one embodiment, the affixation element includes separate fingers ortabs that are secured individually to the second layer. In oneembodiment, the affixation element is attached to the second layer at aregion located generally proximate to a center of the medical devicerelative to a position of the affixation element. In one embodiment, theaffixation element is attached to the second layer at a region locatedgenerally radially outwardly from a center of the medical devicerelative to a position of the affixation element.

A method of implanting a medical device is also included. The methodincludes positioning a medical device against an anatomical structure byexerting a tensile force on a support member of the medical device, thesupport member at least partially located in a pocket formed between afirst layer and a second layer of the medical device secured to eachother and extending outward from the pocket through an opening in thefirst layer, removing the support member from the pocket through theopening in the first layer in order to provide access through theopening to an affixation element located in the pocket and secured tothe second layer, and securing the medical device to the anatomicalstructure via the affixation element. The method of claim 1, whereinremoving the support member from the pocket includes reconfiguring thesupport member via the tensile force to fit the support member throughthe opening.

BRIEF DESCRIPTION OF THE DRAWINGS

The following descriptions should not be considered limiting in any way.With reference to the accompanying drawings, like elements are numberedalike:

FIG. 1 is a perspective view of a medical device according to oneembodiment disclosed herein;

FIG. 2 is a cross-sectional view of the medical device of FIG. 1 takengenerally along sectional line 2-2;

FIG. 3 is an exploded view of the medical device of FIG. 1;

FIGS. 4-11 illustrate prostheses having affixation elements of variousshapes, sizes, and arrangements according to several embodimentsdisclosed herein;

FIGS. 12-19 illustrate various steps of a procedure for using themedical device of FIG. 1 according to one method embodiment disclosedherein;

FIGS. 20-22 illustrate cross-sections of various stages of implantationof the prosthesis into a bodily structure;

FIGS. 23-24 illustrate a prosthesis according to an embodiment disclosedherein; and

FIGS. 25-27 illustrate an embodiment of a support member, a handle, anda cross-section of a portion of the handle engaged with the supportstructure, according to an embodiment disclosed herein.

DETAILED DESCRIPTION

A detailed description of one or more embodiments of the disclosedapparatus and method are presented herein by way of exemplification andnot limitation with reference to the Figures. It is noted at the outsetthat the term “may” is intended to impart optionality of features,parts, materials, components, or composition of the embodimentsdisclosed below.

Referring now to the Figures, FIGS. 1-3 illustrate a medical device 10according to one embodiment disclosed herein. The medical device 10includes a prosthesis 12 and a deployment device 14. It is noted thatcommonly-owned U.S. Patent Publication No. 2014/0025093 to Horton et al.(the '093 publication), and commonly-owned and U.S. Patent ApplicationSer. No. 61/953,615 to Filipiak et al. (the '615 application), whichdocuments are hereby incorporated by reference in their respectiveentireties, describe several embodiments for prostheses and deploymentdevices that are generally applicable to the device 10. That is, theprosthesis 12 and/or the deployment device 14 may be formed accordingto, or include any combination of features of, any of the embodimentsdisclosed in the '093 publication and/or the '615 application. Inaddition to the teachings of these incorporated references, a briefdescription of the prosthesis 12 and the deployment device 14 isincluded herein.

Referring again to the illustrated embodiment, the prosthesis 12includes a first layer 16 and a second layer 18. Due to the orientationduring use, e.g., implantation into a cavity of bodily structure of apatient, the first layer 16 may be referred to as the “top” layer andthe second layer 18 may be referred to as the “bottom” layer. Whenimplanted, the “top” layer may be in closer proximity to the patient'sskin than the “bottom” layer. It is to be understood that prosthesis 12may be used in any spatial orientation and that the terms “top” and“bottom” are for convenience of discussion only. The top layer 16 mayinclude an opening 20 formed therein, while the bottom layer 18 may beformed as a continuous piece of material. The opening 20 may be anyaperture, hole, gap, space, slit, or orifice formed in or by the toplayer 16 that provided access into and out of a pocket 22, or cavity orenclosure, formed between the layers 16 and 18. The layers 16 and 18 maybe integrally formed from a single piece of folded material and/orsecured to each other, e.g., at or proximate to an outer periphery 24,in any desired manner, such as stitching, welding, heat sealing,adhesives, fasteners, etc. For example, according to the illustratedembodiment, the top layer 16 and the bottom layer 18 may be securedtogether at, near, or along a securement region 25 shown in FIG. 3.

The layers 16 and 18 may be made of any suitable biocompatible materialfor implantation into a bodily structure of a patient, e.g., in order toassist in repairing a hernia or other defects in the patient. In oneembodiment, the layers 16 and 18 may be made of a polypropylene mesh,although it is to be appreciated that any other woven or non-wovenimplantable material, e.g., known or used for repairing hernias or otherdefects in a patient's fascia or other bodily structures, mayalternatively be used. In one embodiment, the bottom layer 18 may becoated with or otherwise include an anti-adhesion barrier layer, such asthe omega-3 fatty acid coating commercialized by Atrium MedicalCorp./Maquet Getinge Group and marketed for use with a variety ofsurgical meshes under the trade name C-QUR. Further examples aredescribed in U.S. Patent Publication No. 2006/0078586, U.S. Pat. No.8,124,127, U.S. Patent Publication No. 2009/0181937 and U.S. PatentPublication No. 2009/0208552, each of which is incorporated herein byreference in its respective entirety.

The deployment device 14 includes a support member 26 that is initiallydisposed within the pocket 22 of the prosthesis 12. The support member26 may be formed from or includes a resilient material that enables thesupport member 26 to resiliently or springingly urge the prosthesis intoa generally flat or planar configuration that facilitates positioningand fixation of the prosthesis 12 at the surgical site duringimplantation. Additionally, the support member 26 provides a mechanicalshield or barrier to protect components of the device 10, e.g., thebottom layer 18, and/or bodily structures of the patient that arelocated beneath, below, or on the opposite side of the support member26. For example, a medical professional such a surgeon may need toperform suturing or tacking procedures, and the support member 26 willassist in preventing a needle or tacking tool from inadvertentlydamaging components or bodily structures located on the opposite sidethereof.

In the embodiments disclosed in the '093 publication and '615application, it is intended for a user to secure the prostheses of thoseembodiments in place within a patient by tacks, sutures, or otherfasteners through their respective top layers. As illustrated in FIGS.1-3, the medical device 10 includes the top layer 16, which may be usedto secure the prosthesis 12 in place within a patient, and additionallyincludes an affixation element 28 to provide a structure by whichalternate, auxiliary, and/or supplemental affixation may be achieved, ifdesired by a user at the time of implantation. The affixation element 28is arranged in the pocket 22, located between the bottom layer 18 andthe support member 26. In the illustrated embodiment, both theaffixation element 28 and the opening 20 are arranged proximate thecenter of the device 10, as shown. In one embodiment, the opening 20 andat least a portion of the affixation element 28 are aligned tofacilitate access to the affixation element 28 via the opening 20.

In the embodiment of FIGS. 1-3, the affixation element 28 includes aplurality of securement tabs 30 extending from a hub region 32. Thesecurement tabs 30 may be any shaped or sized fingers, extensions,projections, legs, arms, spokes, etc. The hub region 32 may be securedto the inner surface of the bottom layer 18 in any desired manner, e.g.,via stitching, welds, adhesives, fasteners, etc. The inner surface mayalternatively be referred to as an upper surface or a pocket-facingsurface. For example, an attachment region 34 is illustrated in FIG. 3,which indicates a location at, along, about, within, or proximate towhich the affixation element 28 may be secured to the bottom layer 18 ofthe prosthesis 12. For example, while the region 34 is illustratedhaving a square shape, it is to be appreciated that other shapes in thisgeneral vicinity may be used, such as an X, a circle, a cross or ‘+’, azigzag, a straight line or number of lines, or a random or irregularpattern in the area indicated by the region 34.

It is to be appreciated that any number of the tabs 30 may be included.For example, the affixation element 28 is illustrated having four of thetabs 30 extending from the hub region 32, with each of the tabs beingrelatively long and thin, although a different number of the tabs 30 maybe included (e.g., less than or greater than four, such as one, two,three, five, six, etc.) and that any other dimension and/or shape isalso contemplated (e.g., longer, thinner, wider, shorter, thicker,rectangular, triangular, oblong, circular, semi-circular, polygonal,etc.). In one embodiment, the affixation element 28 is made of abiocompatible mesh, e.g., similar to that described above with respectto the layers 16 and 18, although it is to be understood that otherwoven or unwoven biocompatible materials suitable for receiving asuture, tack, or other fastener for implantation in a patient may beused.

Depending on its particular size and arrangement, the support member 26may initially block access to the affixation element 28 from the opening20. For example, as shown in FIG. 1, hidden lines are used to illustratethe affixation element 28 located “underneath” or on the opposite sideof the support member 26. To this end, the support member 26 may bearranged such that it is capable of being removed from the pocket 22,e.g., thereby enabling the affixation element 28 to be readilyaccessible via the opening 20. For example, in one embodiment, thesupport member 26 has an initial (deployed) surface area that is greaterthan the area of the opening 20, but is reconfigurable in order to beremoved from the pocket 22 via the opening 20. In another embodiment,the support member 26 has at least one dimension that is larger than acorresponding dimension of the opening 20 to create an overlap orinterference between the inner surface of the first layer 16 and thesupport member 26, e.g., which frustrates or hinders the removal of thesupport member 26 from the pocket 22. Examples of particular structurethat enable the reconfiguration of the support member 26 are discussedin more detail below and provided in the embodiments disclosed by '093publication and '615 application incorporated by reference herein. Forexample, reconfiguration can be accomplished by exerting a sufficientlyhigh tensile force on the support member to force the support member 26to twist, contort, pull apart, or otherwise change or alter shape inorder to be removed through the opening 20.

After access is permitted to the affixation element 28 (e.g., followingremoval of at least a portion of the support member 28 from the pocket22), the affixation element 28 provides a structure by which a user canaffix or secure the bottom layer 18 of the prosthesis 12 to the fasciaor other bodily structure of the patient in which the prosthesis 12 isbeing implanted. The affixation element 28 may be secured to the bottomlayer 16, such that affixing the affixation element 28 to a patient'sfascia or other bodily structure will enable a user to position andimplant the prosthesis 12 flush against the patient's bodily structurewithout sagging, drooping, buckling, or unwanted separation of thebottom layer 18 away from the top layer 16 and/or the defect beingrepaired.

It is to be appreciated that the disclosed and claimed medical devicesmay include affixation elements having shapes other than the cross or‘+’ shape of the affixation element 28 shown in FIGS. 1-3. Namely, FIGS.4-11 illustrate several examples of prostheses having differently sized,shaped, configured, and/or arranged affixation elements, although it isto be understood that these are just a few of the many possibleembodiments that those of skill in the art will appreciate in view ofthe instant disclosure. It is appreciated that the medical device 10and/or the prosthesis 12 may include the affixation elements of FIGS.4-11, or features thereof, in lieu of the affixation element 28 shown inFIGS. 1-3. It is also to be understood that while FIGS. 4-11 illustrateonly prostheses, that any deployment device (e.g., the deployment device14) and/or support member (e.g., the support member 26) may be used withthese prostheses if desired.

FIG. 4 illustrates a prosthesis 40 having a first (or top) layer 41 withan opening 42 formed therein and an affixation element 43 affixed to asecond, or bottom, layer 44. The layers 41 and 44 can be secured to eachother similarly to that described above with respect to the layers 16and 18. The affixation element 43 generally resembles the affixationelement 28 of the prosthesis 12 in that it includes a plurality of tabs45 which can be used, e.g., for assisting in securing the prosthesis 40to the bodily structure of a patient. Unlike the affixation element 28,the affixation element 43 does not include a hub region. Instead, thetabs 45 are individual or discrete components that are separatelysecured to the bottom layer 44. The individual tabs 45 of the affixationelement 43 may be affixed to the bottom layer 44 at, along, about,within, or proximate to an attachment region 46, e.g., via stitching,welding, adhesives, or any other manner as discussed herein. As shown,the region 46 is located proximate to a center of the device 40 relativeto the position of the affixation element 43.

FIG. 5 illustrates a prosthesis 50 having a first (or top) layer 51 withan opening 52 formed therein and an affixation element 53 affixed to asecond, or bottom, layer 54. The layers 51 and 54 can be secured to eachother similarly to that described above with respect to the layers 16and 18. The affixation element 53 generally resembles the affixationelement 28 in that it includes a plurality of tabs 55 extending from ahub region 56. Unlike the affixation element 28, the affixation element53 is affixed to the bottom layer 54 via the tabs 55 at, along, about,or proximate to an attachment region 57, e.g., via stitching, welding,adhesives, or any other manner as discussed herein. That is, forexample, the outline of the region 57 may be used as a region forstitching the 55 of the affixation element 53 to the bottom layer 54. Inthis way, the hub region 56 is capable of lifting or separating awayfrom the bottom layer 54, but remains coupled to the bottom layer 54 viathe tabs 55. Opposite to the region 46 of the device 40, it is notedthat the region 57 is located radially outwardly from the center of thedevice 50 with respect to the position of the affixation element 53.

FIG. 6 illustrates a prosthesis 60 having a first (or top) layer 61 withan opening 62 formed therein and an affixation element 63 affixed to asecond, or bottom, layer 64. The layers 61 and 64 can be secured to eachother similarly to that described above with respect to the layers 16and 18. The affixation element 63 generally resembles the affixationelement 28 in that it includes a plurality of tabs 65 extending from ahub region 66. Additionally, the affixation element 63 is affixed to thebottom layer 64 via the hub region 66 at, along, about, within, orproximate to an attachment region 67, e.g., via stitching, welding,adhesives, or any other manner as discussed herein. Unlike theaffixation element 28 illustrated in FIGS. 1-3, the affixation element63 includes eight tabs 65. As stated above, it is to be appreciated thatany number of fingers, extensions, projections, legs, arms, tabs, etc.are contemplated and may be included in other embodiments.

FIG. 7 illustrates a prosthesis 70 having a first (or top) layer 71 withan opening 72 formed therein and an affixation element 73 affixed to asecond, or bottom, layer 74. The layers 71 and 74 can be secured to eachother similarly to that described above with respect to the layers 16and 18. The affixation element 73 generally resembles the affixationelement 63 in that it includes eight tabs 75 extending from a hub region76. Unlike the affixation elements 63 and 28, but similar to theaffixation element 53, the affixation element 73 is affixed to thebottom layer 74 via the tabs 75 at, along, about, within, or proximateto a region 77, e.g., via stitching, welding, adhesives, or any othermanner as discussed herein. In this way, the hub region 76 is capable oflifting or separating away from the bottom layer 74, but remains coupledto the bottom layer 74 via the tabs 75.

FIG. 8 illustrates a prosthesis 80 having a first (or top) layer 81 withan opening 82 formed therein and an affixation element 83 affixed to asecond, or bottom, layer 84. The layers 81 and 84 can be secured to eachother similarly to that described above with respect to the layers 16and 18. Instead of individual fingers, projections, or other extensionsor protrusions, the affixation element 83 is ring-shaped having anopening 85 that forms an inner edge 86 of the affixation element 83 thatis free or unattached to the bottom layer 84, and an outer edge 87 thatis affixed to the bottom layer 84 at, along, about, or proximate tolocation indicated by a securement region 88. Since the inner edge 86 isnot secured to the bottom layer 84, it can be utilized as, and therebyforms, a single, continuous, ring-shaped securement tab. It is notedthat the affixation element 83 and/or the opening 85 formed therein mayhave other shapes, e.g., rectangular, elliptical, oblong, triangular,etc. Additionally in this embodiment, a first pocket is formed betweenthe first layer 81 and the bottom layer 84 and accessible via theopening 82 (e.g., resembling the pocket 22 discussed above), and asecond pocket is formed between the affixation element 83 and the bottomlayer 84 and accessible via the opening 85.

FIG. 9 illustrates a prosthesis 90 having a first (or top) layer 91 withan opening 92 formed therein and an affixation element 93 affixed to asecond, or bottom, layer 94. The layers 91 and 94 can be secured to eachother similarly to that described above with respect to the layers 16and 18. Instead of individual fingers, projections, or other extensionsor protrusions, the affixation element 93 has a circle shape with anouter edge 95 that is free or unattached to the bottom layer 94, and acenter area 96 that is affixed to the bottom layer 94 at, along, about,or proximate to location indicated by a region 97. Since the outer edge96 is not secured to the bottom layer 94, it can be utilized as, andthereby forms, a single, continuous, circular securement tab. It isnoted that the affixation element 93 may have other shapes, e.g.,rectangular, elliptical, oblong, triangular, irregular, etc.

FIG. 10 illustrates a prosthesis 100 having a first (or top) layer 101with an opening 102 formed therein and an affixation element 103 affixedto a second, or bottom, layer 104. The layers 101 and 104 can be securedto each other similarly to that described above with respect to thelayers 16 and 18. The affixation element 103 includes a pair of tabs 105and is secured to the bottom layer 104 at, along, about, within, orproximate to a region 106, e.g., via stitching, welding, adhesives, orany other manner as discussed herein. The tabs 105 can be formed ashalves of a single piece of material that folds or bends at or along theregion 106. It is noted that the shape of the tabs 105 does not have tobe rectangular, but may be any other shape, e.g., triangular,semi-circular, irregular, etc.

FIG. 11 illustrates a prosthesis 110 having a first (or top) layer 111with an opening 112 formed therein and an affixation element 113 affixedto a second, or bottom, layer 114. The layers 111 and 114 can be securedto each other similarly to that described above with respect to thelayers 16 and 18. The affixation element 113 generally resembles theaffixation element 28 in that it includes a plurality of tabs 115extending from a hub region 116. Additionally, the affixation element113 is affixed to the bottom layer 114 via the hub region 116 at, along,about, within, or proximate to a region 117, e.g., via stitching,welding, adhesives, or any other manner as discussed herein. Unlike theaffixation element 28 illustrated in FIGS. 1-3, the affixation element63 includes two tabs 115. As stated above, it is to be appreciated thatany number of fingers, extensions, projections, legs, arms, tabs, etc.are contemplated and may be included in other embodiments.

The aforementioned '093 publication and '615 application teach a varietyof structures that are arranged to undergo reconfiguration for removalfrom a pocket or enclosure via a relatively smaller sized opening, anyof which structures, or features thereof, may be utilized by the supportmember 26. With specific reference to the illustrated embodiment ofFIGS. 1-3, the support member 26 includes a separation line 120 thatenables the support member 26 to unravel as discussed in more detailbelow. It is noted that the separation line 120 may follow any desiredpath or pattern, and that the spiral pattern shown in merely oneexample. The separation line 120 may be, for example, a weakened sectionof material (e.g., a partial through-cut, notch, groove, score, etc.), apreviously separated section of material re-attached in a relativelyweak or separatable manner (e.g., via a temporary adhesive or breakableor removable fastener(s)), a series of perforations, etc. It is to beunderstood that the particular embodiment of the support member 26having the separation line 120 is only one embodiment and that any knownor invented structure capable of reconfiguring for removal from theopening 20 may be alternatively included. For example, the supportmember 26 may be configured to be, or include, one or more bendable orfoldable components, e.g., as discussed below with respect to FIGS. 23and 24, that are capable of the reconfiguration necessary to enable theremoval of the support member 26 from the pocket 22 via the opening 20.

The support member 26 may include a through-cut 122 to facilitateinitiation of separation along the separation line 120. That is, thethrough-cut 122 forms a tab 124 for the support member 26 thatconcentrates forces on or at the separation line 120 when the tab 124 ispulled. For example, the tab 124 may be arranged to act essentially as ashort lever arm to create a moment that is applied to the separationline 120 to facilitate initial separation thereof. A user may use theirfingers, a pair of forceps, etc., to grip or grab the tab 124 and applya pulling force thereon, e.g., angled away from the through-cut 122 andback toward the start of the separation line 120, to initiate separationalong the separation line 120.

A handle 126 may be included by the deployment device, if desired, tofurther facilitate initial release and/or positioning of the medicaldevice 10. Pulling on the handle 126 will result in the support member26 being pulled outwardly with respect to the pocket 22, toward theinner surface of the first layer 16. The inner surface of the firstlayer 16 may alternatively be referred to or thought of as an undersidesurface, or pocket-facing surface. The handle 126 may include at leastone leg, with two legs, designated as legs 128 a and 128 b(collectively, the “legs 128”) shown in FIGS. 1 and 3. The leg or legs128 may be coupled to the support member 26 in the general vicinity ofthe tab 124 and the through-cut 122. To this end, at least one slot,corresponding to the leg or legs 128 is provided. Since there are twolegs 128 in the illustrated embodiment, there is accordingly a pair ofslots designated with the numerals 130 a and 130 b (collectively, “theslots 130”), in which slots 130 a and 130 b the legs 128 a and 128 b arerespectively engaged to couple to the support member 26.

The slots 130 a and 130 b are positioned such that the slot 130 a islocated relatively proximate to the through-cut 122, while the slot 130b is located relative distal therefrom. In this way, forces exerted atthe location of the slot 130 a (e.g., a tensile or pulling force exertedby the leg 128 a of the handle 126 coupled to the support member 26 atthe slot 130 a), will cause the tab 124 to torque or apply a moment onthe support member 26 at the start of the separation line 120, whileforces exerted at the location of the slot 130 b (e.g., a tensile orpulling force exerted by the leg 128 b of the handle 126 coupled to thesupport member 26 at the slot 130 b), will be better distributed acrossthe support member 26 and will not cause the same torquing by the tab124. Stated alternatively, the force required to initiate separationalong the separation line 120 when exerted at or near the location ofthe slot 130 a is significantly less than the force required to initiateseparation when exerted at or near the location of the slot 130 b. Inthis way, the handle 126 can be selectively used by a user to eithermore readily initiate (e.g., via the leg 128 a) or prevent (e.g., viathe leg 128 b) separation along the separation line 120 in response toforces exerted on the support member 26 via the handle 126. It isadditionally noted that pulling on both of the legs 128 a and 128 b willalso help distribute forces to reduce the likelihood of inadvertentinitiation of separation along the separation line. Thus, the handle 126may form both a positioning tool for the medical device 10 (e.g., when auser applies forces through the leg 128 b only, or through both the legs128 a and 128 b, in order to move or position the medical device 10without initiating separation along the separation line) and a removaltool for the support member 26 (e.g., when a user applies forces throughthe leg 128 a only in order to initiate separation along the separationline 120), depending on how it is operated by a user.

The handle 126 may include a lock mechanism 132 to selectively lock thelegs 128 together. The lock mechanism 132 may include a slot 134 formedin one of the legs 128, e.g., the leg 128 a, and a widened head 136formed by the other leg, e.g., the leg 128 b. The head 136 is wider thanthe slot 134 such that it cannot be easily removed from the slot 134without manually rotating the head 136 and pulling the head 136 out ofthe slot 134. The resiliency of the legs 128 can be selected such thatunder no loading the head 136 naturally aligns cross-ways with respectto the slot 134 so that such rotation is necessary to transition thelegs 128 into an unlocked configuration. When in the lockedconfiguration, pulling forces applied to either of the legs 128 will bebetter distributed on the support member 26 so as not to inadvertentlyinitiate separation along the separation line. A similar result may beachieved without locking the legs 128, but instead pulling on both ofthe legs 128 together. It is noted that by making the leg 128 b shorterthan the leg 128 a, pulling forces applied to the leg 128 a will betransferred to the leg 128 a at the lock mechanism 132, and thus exertedon the support member 26 primarily at the location of the slot 130 b. Byreleasing the lock mechanism 132 to unlock the legs 128, the leg 128 acan be readily used to initiate separation along the separation line 120as discussed above.

A method of using the medical device 10 can be better appreciated inview of FIGS. 12-19. A representative structure 140 is illustrated inFIGS. 12-19 and intended to represent a portion or section of a patientinto which the prosthesis 12 of the medical device 10 is to beimplanted. Thus, the structure 140 may be any portion of a patient'sanatomy, e.g., patient's abdominal region, and is understood to includeany tissue/bodily structure into which implantation of the prosthesismay be helpful, e.g., the patient's fascia.

In FIG. 12, the medical device 10 is illustrated with the prosthesis 12and the support member 26 in a rolled configuration. When in the rolledconfiguration, the prosthesis 12 can be inserted into a relativelysmaller opening 142 that provides access to an interior cavity of apatient for implantation of the prosthesis 12 within the patient. Forexample, the opening 142 could be formed as an incision through or intoan anatomical structure made by a surgeon or other medical professionalproximate to the location of the defect being repaired by implantationof the prosthesis 12.

As discussed above, the support member 26 of the deployment device 14 isconfigured to deploy the prosthesis 12 in a generally radially outwarddirection back to a generally flat or planar configuration. FIG. 13illustrates the prosthesis 12 after it has been inserted fully into theopening 142 and permitted to deploy back to its default configurationvia the material properties of the support member 26. For example, thesupport member 26 may be made from flexible, elastically deformable,and/or resilient plastic material. FIG. 14 is a “bottom” view, that is,from the perspective of inside of the patient, of the prosthesis 12after the prosthesis 12 has been inserted through the opening 142 anddeployed to its default configuration by the support member 26.

FIG. 15 illustrates the hand of a user, e.g., surgeon or medicalprofessional, positioning the prosthesis by way of the handle 126. Thelegs 128 of the handle 126 are illustrated in FIG. 15 in theabove-discussed locked configuration via engagement of the lockmechanism 132. In this way, the force required to initiate separationalong the separation line 120, or otherwise reconfigure the supportmember 26 for removal will be relatively high and inadvertent removal ofthe support member 26 unlikely as the user positions the prosthesis 12.Once the prosthesis 12 is suitably positioned, the prosthesis 12 may besecured in place within the bodily structure 140 by tacking, suturing,or otherwise affixing the top layer 16 of the prosthesis to the innersurface of the bodily structure against which the prosthesis 12 ispositioned.

Once the prosthesis is secured in place, the lock mechanism 132 can bereleased, e.g., by rotating the head 136 and pulling the head 136through the slot 134, as illustrated in FIG. 16. Once unlocked, pullingforces applied on the handle 126 may be exerted through the leg 128 aonly. As discussed above, the leg 128 a exerts forces proximate to theslot 130 a, which results in the tab 124 being lifted by the handle 126and applying a moment on the separation line 120, thereby enablingseparation along the separation line 120 when a suitable pulling forceis so exerted. Once separation along the separation line 120 begins, thesupport member 26 will start to unravel into a continuous strip, and bepulled out through the opening 20 as shown in FIG. 17. This unravelingand removal of the support member 26 reveals the affixation element 28that was positioning in the pocket 22 beneath the support member 26.

FIG. 18 illustrates the deployment device 14 after the support member 26is fully unraveled and removed from the prosthesis 12 and the structure140 via the openings 20 and 142. Once the support member 26 is removed,the affixation element 28 may be accessed via the opening 20. Forexample, FIG. 19 illustrates a user using a pair of forceps 144 to pullthe tabs 30 of the affixation element 28 out of the pocket 22 of theprosthesis. The user may then affix, attach, or secure the tabs 30 tothe bodily structure 140, e.g., to the inner surface of the bodilystructure 140 and/or to the tissue along the inner wall of the opening142. Any excess material of the tabs 30 can be folded over or clippedoff, and the opening 142 reclosed.

For further clarity, cross-sectional views of the medical device 10installed in the bodily structure 140 are shown in FIGS. 20-22. It isnoted that many of the components of the medical device 10, e.g., thedeployment device 14, are not illustrated in FIGS. 20-22 for clarity.The anatomy of the representative bodily structure 140 can also bebetter appreciated in view of these Figures, which includes severallayers of tissue 146. More specifically, FIG. 20 illustrates across-section of just the bodily structure 140 having the opening 142formed therein, before insertion of the prosthesis 12. As describedabove, the opening 142 may be formed be an incision made into a patient,as well as from a defect in the tissue 146 that is being repaired.

FIG. 21 illustrates a cross-section after the prosthesis has beeninserted into a cavity formed by the bodily structure 140. This Figurerepresents the prosthesis after it has been secured into place, e.g.,via sutures, tacks, etc., and the deployment device 14 removed, as thetabs 30 of the affixation element 28 are illustrated extending outwardlythrough the opening 142. There is noticeable drooping, sagging, orbuckling of the bottom layer 18 depicted in FIG. 21, which may occurprior to utilizing the affixation elements 28. It is noted that thisdrooping, sagging, or buckling, is exacerbated in relatively largerprosthesis due to the increase amount of unsupported material. Withoutthe affixation elements, e.g., the affixation elements 28, describedherein, this drooping, sagging, or buckling may result in theundesirable accumulation of fluid, i.e., a seroma. Additionally, it isdesirable for the tissue 146 to grow into and around the layers 16 and18 of the prosthesis 12. The drooping, sagging, or buckling of thebottom layer 18 may frustrate or delay this desired tissue ingrowth.

FIG. 22 illustrates the prosthesis 12 after the tabs 30 of theaffixation element 28 have been secured to the bodily structure 140,e.g., via a suture 148, or other fastener, into the tissue 146 liningthe walls of the opening 142. As can be better appreciated by comparingFIGS. 21 and 22, the bottom layer 18 can be pulled toward the top layer16 and supported from the aforementioned drooping, sagging, or buckling,by securing the tabs 30 of the affixation element 28 to the tissue 146.In this way, the prosthesis 12 can be positioning and secured more fullyand flushly against and conforming to the contours of an inner surface148 of the bodily structure 140. After securing the tabs 30 in place toassist in supporting the prosthesis 12, any remaining portion of thetabs 30 may be cut off, e.g., as indicated by a line 149.

As discussed herein, other support members, deployment devices, andhandles may be used or interchanged with those illustrated in FIGS. 1-3.For example, FIGS. 23 and 24 illustrate a medical device 150 accordingto another embodiment disclosed herein. The medical device 150 includesa prosthesis 152 and a deployment device 154. The prosthesis has top andbottom layers as discussed above with respect to the layers 16 and 18,with a top layer 156 including an opening 158 therein. Unlike thedeployment device 14, a support member 160 of the deployment device 154is formed by two portions 162 that together provide a similar resilientdeployment function as the support member 26, e.g., due to materialproperties of the support member 160. It is to be appreciated that anynumber of portions 162 may be included. A handle 164 including two legs166 is coupled to the support member 160. When a pulling force isexerted on the support member 160 via the handle 164, as indicated byarrows in these Figures, the support member 160 is able to undergo areconfiguration suitable to enable the support member 160 to be removedthrough the opening 158. That is, a pair of gaps 168 adjacent to theportions 162 enables the support member to reconfigure into a relativelysmaller size by bending and/or folding, as illustrated in FIG. 24.Although not illustrated in these Figures, it is understood based on theabove description that an affixation element, e.g., the affixationelement 28, may be located “beneath” the support member 160 within thepocket formed by the prosthesis 152.

Another example of a deployment device is illustrated in FIGS. 25-27,namely, which includes a support member 170 as illustrated in FIG. 25and a handle 172 as illustrated in FIG. 26. The handle 172 isillustrated with a generally T-shaped configuration, although it is tobe appreciated that it could take other shapes. The support member 170resembles the support member 26 in several respects, e.g., resilientmaterial composition, a through-cut 174 and a separation line 176, whichcomponents resemble in form and function their counterparts from thesupport member 26. Unlike the support member 26, the support member 170includes, instead of the slots 130 a and 130 b, an opening 178 havingtwo circular overlapping portions 180 a and 180 b (collectively, “theportions 180”). The opening 178 is arranged to receive a connector 182of the handle 172. The connector 182 may include a head 184, e.g., aflange, cap, shoulder, lip, etc., that is connected to the rest of thehandle 172 via a recessed portion 186. The dimensions of the head 184,e.g., the radial dimension, may be selected such that it is greater thanthe corresponding size of the portions 180 of the opening 178. In thisway, for example, after the head 184 is snapped, pressed, squeezed,forced, or otherwise passed or positioned through the opening 178, therelatively larger dimensions of the head 184 prevent, or otherwisefrustrate or make more difficult, disengagement of the connector 182from the opening 178.

The circular portion 180 a may be arranged similar to the slot 130 a(that is, positioned relatively proximal to the through-cut 174), whilethe circular portion 180 b may be arranged similar to the slot 130 b(that is, positioned relatively distal from the through-cut 174). Inthis way, the handle 172 can function generally similar to the handle130, in that forces can be more readily applied to the semi-circularflap or tab formed by the through-cut 174 in order to assist ininitiating separation along the separation line 176, e.g., into acontinuous strip along the path defined by the separation line 172similar to the discussion of the separation line 120 discussed above.Likewise, similar to the slot 130 b, the portion 180 b is positionedrelatively distal from the through-cut 174. In this way, forces appliedto the support structure 170 at the location near the portion 180 b aremore evenly distributed through the support structure 170. It is thusnoted that moving the handle 172 between engagement with the circularportions 180 a and 180 b results generally in the same functionality aslocking and unlocking the lock mechanism 132 as discussed above.

While the invention has been described with reference to an exemplaryembodiment or embodiments, it will be understood by those skilled in theart that various changes may be made and equivalents may be substitutedfor elements thereof without departing from the scope of the invention.In addition, many modifications may be made to adapt a particularsituation or material to the teachings of the invention withoutdeparting from the essential scope thereof. Therefore, it is intendedthat the invention not be limited to the particular embodiment disclosedas the best mode contemplated for carrying out this invention, but thatthe invention will include all embodiments falling within the scope ofthe claims. Also, in the drawings and the description, there have beendisclosed exemplary embodiments of the invention and, although specificterms may have been employed, they are unless otherwise stated used in ageneric and descriptive sense only and not for purposes of limitation,the scope of the invention therefore not being so limited. Moreover, theuse of the terms first, second, etc. do not denote any order orimportance, but rather the terms first, second, etc. are used todistinguish one element from another. Furthermore, the use of the termsa, an, etc. do not denote a limitation of quantity, but rather denotethe presence of at least one of the referenced item.

What is claimed is:
 1. A medical device, comprising: a first layerhaving an opening formed therein; a second layer positioned with respectto the first layer to form a pocket therebetween; a support member atleast partially located in the pocket and reconfigurable to enableremoval of the support member from the pocket via the opening, whereinthe support member includes a spiral separation line that enables thesupport member to unravel as material separates along the separationline when reconfiguring for removal via the opening; and an affixationelement located in the pocket between the support member and the secondlayer, and secured directly to a pocket-facing surface of the secondlayer by a component selected from the group consisting of stitching, aweld, an adhesive, and a fastener.
 2. The medical device of claim 1,wherein the affixation element is secured to the second layer at asecurement region, and the affixation element is secured to the secondlayer at a location separate from the securement region.
 3. The medicaldevice of claim 2, wherein the affixation element is at least partiallyformed by a mesh material.
 4. The medical device of claim 1, wherein theaffixation element is at least partially blocked from access through theopening when the support member is located in the pocket.
 5. The medicaldevice of claim 1, wherein the affixation element is able to at leastpartially extend out from the pocket through the opening when thesupport member is removed from the pocket.
 6. The medical device ofclaim 1, wherein the medical device can be held against an anatomicalstructure by the support member when the support member is at leastpartially located within the pocket, and by the affixation element whenthe support member is fully or at least partially removed from thepocket.
 7. The medical device of claim 1, wherein the pocket isdelimited by an underside surface of the first layer and thepocket-facing surface of the second layer.
 8. The medical device ofclaim 7, wherein a tensile force is able to be applied to the medicaldevice at (i) the underside surface of the first layer by the supportmember and (ii) at the pocket-facing surface of the second layer by theaffixation element.
 9. The medical device of claim 1, wherein thesupport member has at least one dimension that is larger than acorresponding dimension of the opening to frustrate or impede removal ofthe support member from the pocket.
 10. The medical device of claim 9,wherein the support member is reconfigurable in response to a tensileforce applied to the support member in order to remove the supportmember from the pocket via the opening.
 11. The medical device of claim1, wherein the affixation element includes one or more tabs extendingfrom a hub and the hub is affixed to the pocket-facing surface of thesecond layer.
 12. The medical device of claim 1, wherein the affixationelement has a circular shape or a polygonal shape.
 13. The medicaldevice of claim 1, wherein the affixation element includes separatefingers or tabs that are secured individually to the pocket-facingsurface of the second layer.
 14. The medical device of claim 1, whereinthe affixation element is attached to the pocket-facing surface of thesecond layer at a region located generally proximate to a center of themedical device relative to a position of the affixation element.
 15. Themedical device of claim 1, wherein the affixation element is attached tothe pocket-facing surface of the second layer at a region locatedgenerally radially outwardly from a center of the medical devicerelative to a position of the affixation element.
 16. A method ofimplanting a medical device comprising the steps of: positioning amedical device against an anatomical structure by exerting a tensileforce on a support member of the medical device, the support member atleast partially located in a pocket formed between a first layer and asecond layer of the medical device that are secured to each other, andthe support member extends outward from the pocket through an opening inthe first layer, wherein the support member includes a spiral separationline that enables the support member to unravel as material separatesalong the separation line when reconfiguring for removal via theopening; removing the support member from the pocket through the openingin the first layer in order to provide access through the opening to anaffixation element located in the pocket and that is secured directly toa pocket-facing surface of the second layer via stitching or welding oran adhesive or fasteners; and securing the medical device to theanatomical structure via the affixation element in order to preventsubstantial drooping, sagging or buckling of the medical devicepositioned against the anatomical structure.
 17. The method of claim 16,wherein removing the support member from the pocket includesreconfiguring the support member via the tensile force to fit thesupport member through the opening.
 18. A medical device, comprising: afirst layer having an opening formed therein; a second layer positionedwith respect to the first layer to form a pocket therebetween; a supportmember at least partially located in the pocket and reconfigurable toenable removal of the support member from the pocket via the opening,wherein the support member includes a spiral separation line thatenables the support member to unravel when reconfiguring for removal viathe opening; and an affixation element located in the pocket between thesupport member and the second layer, and secured directly to apocket-facing surface of the second layer via affixation means.
 19. Themedical device of claim 18, wherein the affixation means is selectedfrom the group consisting of a stitching, a weld, an adhesive and afastener.